Supercharged immune cells take on post-transplant viruses
NCT ID NCT04331275
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to treat viral infections that often occur after a solid organ transplant. Researchers create special immune cells, called viral-specific T-cells, from the patient's own blood to fight the virus. The goal is to reduce the need for strong anti-viral drugs and lower the risk of organ rejection. The study includes 42 participants who have certain viral infections after their transplant.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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42 people
The number who actually took part.
- Started
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Aug 2020
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Blood adenovirus PCR ≥1,000 * Blood CMV PCR ≥ 500 * Blood EBV PCR ≥ 1,000 * Plasma BKV PCR \>1,000 * Plasma JC Virus PCR \> 1,000 * Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx. * Evidence of invasive CMV infection, e.g. pneumonitis, retinitis, colitis. * Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation. * Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, BK viruria or BK nephropathy * Evidence of PML or other CNS infection due to JC virus * Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent, or a clinically acceptable steroid dose at the discretion of the PI * Age \> 1 day * Must be able to receive VST infusion in Cincinnati Exclusion Criteria: * Uncontrolled bacterial or fungal infection
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Banked t cells target four viruses at once in children after transplant
- A simple blood test may spot severe bacterial infections faster in the ER
- Can cord blood t cells be trained to stop viral infections after transplant?
- Can a new IV antiviral tame two stubborn viruses?
- Can specially grown immune cells from donors beat viruses that won't go away?
- A new drug combo may shield kidney transplant patients from a common viral threat